]]>http://blog.cliniindia.com/2017/07/20/pharmacovigilance-interview-questions-answers-video/feed/0153Watch this video for Basic Interview Questions and Answers – Very useful for freshershttp://blog.cliniindia.com/2017/07/18/watch-video-basic-interview-questions-answers-useful-freshers/
http://blog.cliniindia.com/2017/07/18/watch-video-basic-interview-questions-answers-useful-freshers/#respondTue, 18 Jul 2017 07:09:54 +0000http://blog.cliniindia.com/?p=144The post Watch this video for Basic Interview Questions and Answers – Very useful for freshers appeared first on Clinical Research Blog.
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]]>http://blog.cliniindia.com/2017/07/18/watch-video-basic-interview-questions-answers-useful-freshers/feed/0144Here are the Recent Updates by DCGI which will ultimately attract new trials in Indiahttp://blog.cliniindia.com/2017/07/18/recent-updates-dcgi-will-ultimately-attract-new-trials-india/
http://blog.cliniindia.com/2017/07/18/recent-updates-dcgi-will-ultimately-attract-new-trials-india/#respondTue, 18 Jul 2017 06:44:31 +0000http://blog.cliniindia.com/?p=138Recent Updates by DCGI which will ultimately attract new trials in India: 1) Confirming the turnaround time for approvals and making the deadline as 180 days for all Global...

]]>Recent Updates by DCGI which will ultimately attract new trials in India:

1) Confirming the turnaround time for approvals and making the deadline as 180 days for all Global Clinical Trials.

2) Drafting a revision over the last update done as 122 DAB over the compensation for the trail related injuries. Also order released confirming that compensation for death or trial related injuries should be paid to the trial subject or nominee if any drug related anomaly is been identified and accepted.

3) Now instead of just one NDAC, now load of new drug clinical trial approval will go in two layers primarily first review by SEC (Subject Expert Committee) and their recommendations will be reviewed by TRC (Technical Review Committee) and finally CDSCO will grant approval from TRC recommendations. This will now decrease the turnaround time of clinical trial approval.

4) Limitations for Investigator to undertake maximum of 3 trails will ensure more accountability and least chances of negligence in clinical trials.

5) Though Phase I clinical trial is exempted for medical devices but procedure for clinical trial approval, accreditations of investigators, sites, ethics committee and such other conditions will remain same.

6) All trail subjects will be provided with primary care for any illness during their trial participation this may be within the site or hospital.

7) Academic studies will be conducted upon approval by IEC but if there is any new drug or new use of an existing drug involved then it requires DCGI approval.

8) Clinical trial for new drugs which are already approved in other countries outside India can be waived if it’s for national emergency, extreme urgency and conditions / diseases for which there is no therapy.

9) There were factors which will be now reviewed by SEC which will decide if there are ethnically sensitive or insensitive before giving approval to any clinical trial.

10) It has been decided if Indian patients have been participated in phase III global clinical trials; the number of participants would have adequate considering the approval of drug in India.

11) Generics/ Biosimilars for countries like USA that have been marketed there for > 4 yrs & have a satisfactory report would be approved for marketing in India after abbreviated trials. 12) Considering the placebo control to be very uncommon CDSCO considered there should be an existing therapy to compare the test drug. It should be appropriate, efficient and ethical.

13) If Indian population is participating in global clinical trials and for indication which is prevalent in India so in that sponsor/ innovator should market this NCE in an expedited way by manufacturing. This needs to be confirmed in the form of undertaking while submitting the application.

14) If two or more countries have removed drug from the market in grounds of safety and efficacy then the continued marketing of the drug will be subjected to examination and action.

15) CDSCO require post marketing surveillance of drugs, rational use of drugs, drug utilization studies and adverse drug reactions monitoring so for the same there was a cell constituted within CDSCO which will be working with ICMR for the sponsoring various studies.

]]>http://blog.cliniindia.com/2017/07/18/recent-updates-dcgi-will-ultimately-attract-new-trials-india/feed/0138Most Important – Basic Interview Questions and Answers (Video)http://blog.cliniindia.com/2017/07/17/basic-interview-questions-answers-video/
http://blog.cliniindia.com/2017/07/17/basic-interview-questions-answers-video/#respondMon, 17 Jul 2017 05:58:33 +0000http://blog.cliniindia.com/?p=133Watch this video to find the answers of these questions- Tell me about yourself. What are your strengths ? What are your strengths ? Why have you chosen this field? ...

]]>http://blog.cliniindia.com/2017/07/17/basic-interview-questions-answers-video/feed/0133What to avoid during fresher interview ? Article by HRhttp://blog.cliniindia.com/2017/07/15/avoid-fresher-interview-article-hr/
http://blog.cliniindia.com/2017/07/15/avoid-fresher-interview-article-hr/#respondSat, 15 Jul 2017 07:29:30 +0000http://blog.cliniindia.com/?p=129Having done HR interviews for almost 8 years for various MNCs, I have seen many freshers getting rejected in their HR interviews. I have found myself thinking that they could...

]]>Having done HR interviews for almost 8 years for various MNCs, I have seen many freshers getting rejected in their HR interviews. I have found myself thinking that they could have nailed that job, if only they had better guidance. I am writing this article to help freshers understand what goes on in an HR interviewer’s mind based on my experiences.

Firstly, it is important that you understand why you are having an HR interview. Companies do HR interviews to evaluate:a) Your attitude towards work. b) Your aptitude towards work.c) Your confidence. d) Your communication skills. e) Your fitment into the organization.

Remember, as a fresher with no prior experience, your evaluation will mostly rely on how you conduct yourself during the interviews.

Below are the 5 common mistakes that I have seen freshers make during an HR interview and what impressions it creates.

The First Impression: This sets the tone for the rest of the interview and recovering from a mistake made here is very difficult. You will spend the rest of the interview time trying to regain lost ground. Here are some common mistakes that I have seen.

The resume with spelling and grammatical errors : How can the company trust you with more responsibilities if you cant make your own resume carefully? Spend quality time on getting your resume right and get it proof-read multiple times.
The casual dresser ( jeans / floaters etc. ): Are you not serious about work? Even if company policy allows you to wear jeans to work, remember that you are not yet employed there. Being dressed in formals creates a better impression.
The shoddy dresser : Unironed / dirty clothes / shoes have no excuse and makes me think that you are careless. If there is an explanation for it, share it right at the beginning of the interview. It makes you genuine.
The latecomer : Not only do you not value time, you may not understand importance of meeting deadlines or communicating about it. If you are going to be late due to unavoidable reasons, make sure to call ahead and inform. Also, apologise at the start of the interview.
Being disorganized : Torn documents / haphazardly stored documents creates an impression that you are disorganised. Carry all documents in a neat folder.

Research : There has been a lot said about researching a company and understanding what they do. A few things to avoid here:

Saying ” I didn’t have time to go through your website ” : And I think “This is your first job and you cannot even be bothered to learn about a company you might work for?”
Saying “I didn’t understand what you meant on your website”: I feel like you didn’t put enough effort and you are not persistent enough. Spend enough time to understand the company and the work they do. Find someone who works at the company and get an insider perspective.

Be Honest : You would be surprised at how far honesty can take you in an interview. These common statements can cause you to lose trust during the interview:

Saying ” I had some personal problems ” : If you can actually share what the personal problem was, I will be on your side and you can build trust . If you are unable to share it, clarify that as well so you still sound honest.
Saying ” I don’t have any weaknesses ” : I think that you are not self aware and lack the ability to understand yourself. Also, recruiters always see through if you are trying to make a positive sound like a negative.” My weakness is that I am too committed and I work extra hours” – Duh, Really??. Spend some time analysing your strengths and weaknesses and have examples from your life to back it up. These examples can be during your school / college years or even drawn from your personal life.
Saying ” I want to join your company because of challenging work” – I feel that you have not done enough research on the company and what it does. Hence you are not able to articulate how your interests fit in to what the company does.

Body Language : Your body language during the entire interview process can either make or break your interview.

The limp handshake / Sloucher : Not having a firm handshake and slouching throughout the interview makes you look like you are not confident. Practice shaking hands till you have a firm grip and smile when shaking hands. Also, sit straight with your shoulders back during the interview. This makes you more alert and attentive.
Too relaxed : Leaning back in your chair during the interview makes the recruiter think that you are not serious about getting the job.
Nervousness : Looking at your hands or around the room / Playing with your hair instead of looking at the recruiter will not make them believe that you are confident. AT the same time, don’t glare at them either Remember to look at the interviewer when you answer.
Voice Modulation : Not modulating your voice appropriately during the interview to reflect your enthusiasm / emotions appropriately can make you seem nervous or that you are not being genuine. Remember, recruiters can identify if you are really nervous.

The Ending : You will generally get an opportunity to ask questions at the end of the interview. The following statements tend to be very weak and should be avoided.

“I don’t have any questions”
“I have already asked the other interviewers”
Asking salary related questions before the job confirmation

Note that there is no right or wrong answer in HR interviews. All these tips can just ensure that you are not rejected for reasons that are within your control. Its important to be yourself and present your best side during the interview.

Prepare a list of commonly asked questions and say the answers out loud in front of a mirror. What is most critical for a winning HR interview is this practice. Listen to yourself, record it if you can. Get some trusted friends or family members to listen to it and continually refine it.

1) Tell me a little about yourself.

Following are 4 sample answers Sample Answer #1

I am XYZ, a pharma graduate from ABC. I like to apply my analytical skills to develop world class products in the XYZ domain. When I am not working, I volunteer to NGO’s as it gives me an opportunity to serve needy people. I also travel a lot and an active member of XXX travel group or club through which I could explore my hobby more.

Sample Answer #2

As a technical project manager, I have more than six years of experience at top Wall Street Companies. In recent company, I led the development of an award winning new trading platform. I am a person that survives in a fast-paced environment. At moment, I am looking for a chance to apply my technical expertize and my creative problem solving skills at an innovative software company like this one.

Sample Answer #3

Since last 4-5 years, I am deeply involved with my administrative work. I have always been interested and enjoyed working in the computer industry, but I consider myself lucky that I got an opportunity to work at different levels like business analyst, programmer and assistant manager. My main strength is the ability to maintain a great rapport with the customer and my attention to their details.

Sample Answer #4

I am one of the top graduates of my batch in College. I am known in school as an organizer, having held several committees and organizations since my first year. I am a dedicated person who never stops working on something until it is perfect. It would be a pleasure for me to discuss how I can be such an asset to your company.

Tips:

Try to cover your accomplishment in your answer

Talk about the work or project that resembles the requirement of the position Mention what led you to this point in your career and why job is the perfect match for you

Don’t narrate anything that is personal

End your answer by telling them you want the position and why

Use selective terminology in your answer like problem solving, innovative, fast-paced, creative and so on

What not to say:

2) Why do you want to work in this company?

4 sample answers Sample Answer 1:

I would be proud to work for a company like yours with such a long history of leadership in the industry. I have carried out web research and believe that the company’s XYZ products and its future projections are very impressive and promising. The XXX team is the team I would take pride to work with. A place where my skills or background fits perfectly and can be utilized respectively.

Sample Answer 2:

Your company made its fortune for making great products that help people do X. But on top of that it is the kind of place where I can fit in and excel, so I was thrilled to see you have this opening. Your company believes in providing superior service, to which I share the same value and enables me to not only fit into your organization but complement the team as well.

Sample Answer 3:

I was delighted to see on your website that your feature employees are talking about how great it is to work for your company. These days so many people seem to despise where they work for one reason or another. It’s wonderful to see that your employees are proud to talk about how much they love their jobs.

Sample Answer 4:

This company is on the list of most admired companies every year. I want to play a role in ensuring this company stays on that list. I want to be part of a company that offers no less than quality in terms of products and after sales services.

Tips:

Conduct a thorough research of company and company’s top executive before facing interview

Learn about the company’s vision and how you can contribute to it Demonstrate your eagerness to work for the company

Evidence that you understand the employer’s business

Mention why you rely on XYZ company for your growth and why it is the best place to utilize your skill and experience for the benefit of the company

Demonstrate your belief in company’s product or service

3) Do you consider yourself successful?

5 sample answers Sample answer #1

I feel successful with continuous progress. I find exciting when I am allowed to implement new ideas and see its fruition. I would define my success as what I have learned through years and use them when circumstances arises or demands.

Sample answer #2

I feel successful when I meet my short term as well as the long-term goals. I try to achieve the set goals and work hard as much as I can, I try to reach those goals and achieve the desired outcome. I want to recognize myself as someone with a progressive attitude who does his best and gives 100% to attain goals. To me success is not just my personal achievements but also by the efforts of the people around me.

Sample answer #3

Success to me is knowing that I am excelling in my performance and filling fulfilled. My work should add value to the company and its customers. Knowing that each day I am making the world a better place is a success to me. I would define success at work as what I have learned from key job assignments experiences.

Sample answer #4

Success to me is spending the majority of the time focused on work that are fulfilling and increasing my efficiency to help the organization grow. While I also believe that greater success can be achieved while working as a team towards a common goal.

Sample answer #5

Yes. During myyear career, I have learned to set goals and to make sure I meet each of it. I make sure obstacles do not hinder me from reaching my goals, but instead should inspire me to exert more. I believe the new position I am applying for will enable me to reach up higher and be more successful

Tips:

Summarize your career goals

Don’t say something that sound self-centric.

4) Are you willing to travel?

Yes. I love traveling. Adjusting in new places and meeting new people would be a delightful experience for me.

5) What are your salary expectations?

As of now, I haven’t thought much about it. I’m more focused on learning the requirements for this position that I am applying for.

6) What would you consider your greatest strengths & weakness?

3 sample answers Sample answer #1

My strength is my ability to convert negative work environment into a positive and at the same time, developing a supportive team. I am also capable of keeping many projects on track and ensuring deadlines are met. As far as my weakness is concerned I get impatient sometimes in order to get everything done very quickly. To tackle the problem, I am trying to re-consider the to-do list and prioritize the tasks.

Sample answer #2

I am very comfortable working with a different group of people. My strength is my analytical and planning skills, developed over the years, help me to complete my work before the deadline. I am a little bit nervous while speaking in a group, but I have given good number of paper presentation to overcome this.

Sample answer #3

I’m a highly motivated person. I don’t stop until I get things done. I value other people’s time and company’s resources. I work to become an asset, not a liability.

People say I sometimes act too much as a perfectionist. To counter this, I attended seminars that teach me how to manage myself well.

Tips

Focus mostly on strengths

Show the interviewer how you are putting effort to overcome the weakness Mention about your real weakness but do mention about how you are going to fix it Make sure your strength and weakness don’t contradict each other

Research well about the position you are applying for and identify the area where you can apply your strength

Choose a weakness that is acceptable for the job in hand Don’t confuse interests with strength or dislikes with weakness.

7) What motivates you?

4 sample answers Sample Answer #1

I am very result-oriented person; my primary motivation is to achieve the desired end result. While I enjoy working on the project of my own, I am particularly motivated by the buzz of working in a team. It’s very exciting working closely with others, who share the same common goal. I also like to take on the challenge, and rise to that challenge as part of a concerted team effort.

Sample Answer #2

Primarily, my ability to work hard and delivering result motivates me. But subsequent recognition of my efforts gives me the encouragement for my next efforts.

Sample Answer #3

Responsibility towards work motivates me the most and my aim within any company is to move up to greater levels of responsibility to achieve each goal with better responsibilities.

Sample Answer #4

Many things motivate me. My goal to be the best of what I can be often motivates me to go beyond my own expectations. When I see myself being productive everyday, it motivates me to continue.

Tips:

Sometimes, the best solution is to be honest- you can say money is your motivational factor, but it should be your last option

Mention things like Job satisfaction, working towards a goal, contributing to a team effort or developing your skills- provide a specific example that supports your response Excitement for new challenges

Quest for personal development.

What not to say:

Do not mention that you are motivated by bragging rights, material things or fear of being disciplined.

8) Why should we hire you?

5 sample answers Sample Answer 1:

In my XXX years of experience as a manager, I have build-up a solid motivational and team- working skills. I was awarded twice as the manager-of-the-year for my excellent methodologies for motivating employees to encounter challenges and meeting deadlines. If hired, I will carry forward this ability of leadership and strategies for achieving profit gains to this position.

Sample Answer 2:

The subjects I chose while working for my degree in XXX subject have prepared me for this particular post. Also, my two-year experience working with company X has given me

the platform to master the skills that I needed to deliver for this position. It seems as if I was prepared all my life to land this job.

Sample Answer 3:

For this particular job, I have the perfect combination of skills and experience that is required. I also bring the experience of strong analytical and problem-solving skills that I have gained while working with other companies. My dedication to excellent work standards will add value to the team and the company.

Sample Answer 4:

I am quite aware of the company’s mission of acquiring the largest consumer base in the area and to become the front-runner in supplier’s or provider’s community. My domain knowledge and hold over the customer base can make a big contribution towards this. I would really enjoy this challenge of growing this business bigger.

Sample Answer 5:

As I have said earlier, my years of experience in this field is something that can truly contribute to this company’s success. My sense of dedication in every task that I handle is definitely a big plus. I believe my skills and work attitude measures up to your company standards.

Tips:

State or provide some evidence that shows how you contributed to the growth of the previous company in terms of revenue, goodwill, and brand

Include your research you made on the company- for a smaller company you can say- your company is open to new innovative ideas

What not to say

Try to avoid saying- I need a job, money or this place is close to where I live Focus on what can you do for the company rather than what they can do for you

NEVER DO THIS- comparing your skills to others. The natural instinct to this question is we usually start comparing our skills to others, when this question is put through.

9) Are you a team player?

Yes, definitely. While I will deny the fact that I can work independently with minimal supervision, I’m also one companion every leader would ever wanted to be in his team. Whatever task is assigned to me, I make sure it meets and exceeds what is expected of me. I also make it a point to reach out to teammates whenever needed.

10) What is your philosophy towards work?

I have only one philosophy when it comes to work: every piece of work, regardless of size, has to be done on time and in the right manner.

11) What have you learned from mistakes on the job?

I learned that without proper coordination, even the simplest task could cause problems in a project. I had this problem during my first job. From that time on, I made sure every I thing follows every detail and coordination.

12) Describe your management style.

Basically, my management style comes with promptness and flexibility. To make sure goals are achieved, I religiously study and make plans down to the smallest detail. While I do implement a strict sense of being time bounded, I also add reasonable allowances and make room for contingencies.

13) How would you know you were successful on this job?

Being successful means goals that are set are met. Being successful also means standards are not only reach, but also even exceeded wherever possible.

14) Are you willing to work overtime? Nights? Weekends?

I understand that being asked to work for an extended number of hours comes with a good reason in the first place, so I’m ok with it. It an extra effort means something for the company, I’ll be happy to do it.

15) What will you do if you don’t get this position?

I have high hopes that I will be hired. In case it turns the other way around, I would have to move on and search for another job.

16) What have you done to improve your knowledge in the last year?

I have attended in several self-improvement, time management and personality development seminars. I have also participated in training workshops related to [industry].

17) How you would be an asset to this company?

My skills in […] are outstanding. I have earned a lot of awards and certifications from my past employers. As an employee, I handle pressure with ease and can work with minimal supervision.

18) How long would you expect to work for us in case you are hired?

As much as possible I would like to be in this company for a long time. For as long as management sees me as an asset, I am willing to stay.

19) Describe your ability to work under pressure.

I understand the nature of this position that I am applying for quite well, along with the pressure that comes with it. Being under pressure doesn’t discourage me, it motivates me more.

20) Tell me about a problem you had with a supervisor.

I’m sorry but I can’t recall any instance when I had such a problem with a supervisor.

21) Why do you think you would do well at this job?

Because, I love this job. I feel very confident of myself and my ability to delivery nothing short of quality output. My years of experience helped me develop these skills.

22) What irritates you about co-workers?

I always get along fine with my co-workers. I tend to be open minded and very considerate.

23) Do your skills match this job or another job more closely?

I feel my skills are best fit for this job.

24) What has disappointed you about a job?

I once felt that I was not being given enough challenges to work on. I was a bit disappointed because I was so eager to go for more.

25) If you were hiring a person for this job, what would you look for?

I would look into two essential things: the ability to do the job right and the proper attitude to do it. Skills without the right attitude will not contribute to a productive output.

26) What role do you tend to play in a team?

I tend to be versatile when it comes to being a team player. I can act as a leader, an assistant, a communicator, a secretary, whatever role that will ensure the success of the team. That’s because understanding the different roles will allow each player to take on the roll of the other in times of need.

27) What was the most difficult decision for you made?

It was a time when I had to choose between joining a group of employees protesting some issues in the company, and staying away from the issue. I ended up being a mediator between the employees and our immediate supervisor, and I was glad I made that decision because it all ended well and without further conflicts in the work place.

28) Are you willing to make sacrifices for this company?

I would be willing to do that to the best of my ability. I can manage personal matters on my own without causing conflicts when management needs me most. However, I will not comprise on my values.

29) What qualities do you look for in a boss?

I look into my boss as a person who can easily relate with me, can make firm decisions, and is transparent. A boss with a sense of humor would also be a delightful idea.

30) Are you applying in other companies as well?

Yes. I have submitted my applications in some of the best companies like [….]. Above all, my priority and hope is that I be able to land a job in your company.

31) Do you know anyone who works in our company?

No. I found your ads in a popular job posting website.

32) How do you propose to compensate for your lack of experience?

I am a quick learner. Every time there is something new to me, I take time to study it at the soonest time.

33) Have you ever worked in a job that you hated?

Not exactly hated. I once had a job that does not exactly match my qualification. Nevertheless, I was glad I took the job because it was an opportunity to learn something new and added to my list of experience.

34) What would your previous supervisor say your best point is?

Some of my strongest points at work are being hardworking, patient and a quick learner.

35) What is the most difficult thing about working with you?

My co-workers often say I’m too serious about my work. However, I have attended some personality enhancing seminars to blend better with co-leagues.

36) What suggestion/s have you made in your previous employment that was implemented?

I once suggested that management and staff should have more regular meetings instead of quarterly meetings. I was happy that management took note of this and even commended me for making a good initiative.

37) Would you rather be liked or feared?

I would like to be liked, but more importantly, I would prefer to be respected. Being feared does not necessarily command respect.

38) How do you cope with stress?

I pause for a few minutes, look out into the window. Brief pauses in enough to get me charged again. I can manage stress well enough and does not decrease my productivity level.

39) Would you rather work for money or job satisfaction?

Job satisfaction is more important for me. Working just for the money may not be fulfilling if I don’t like the job in the first place. Job satisfaction makes me stay productive; money would naturally come along well.

40) Describe your work ethics.

Always give your best in every job, if not, don’t do it at all.

41) What was your biggest challenge with your previous boss?

My previous boss was very strict when it came to deadlines and output. It was a challenge for me to meet every expectation he made. It was also a good learning experience for me because it only made me better at what I do.

42) Do you enjoy working as part of a team?

Yes, I enjoy it very much. Being part of a team means you get to contribute for the good of all, while at the same time there’s are members who can support you and share more knowledge with you.

43) Why should we hire you?

Because I believe my talents and skills will definitely be a big contribution to your company’s continuing pursuit of excellence. I’m a fast worker and hardworking person who can be very reliable asset to this company.

44) Has anything ever irritated you about people you’ve worked with?

I go along fine with co-workers. When I feel the other guy’s attitude is a negative one, I try my best to approach him and talk things over. I always make it a point to stay positive and transparent with people around me.

45) Do you have any questions for me?

I would like to know what are the next step for me. I would also be interested to know more about the details of this position I am applying for.

46) Where do you see yourself in 5 years?

This is a popular interview question asked in mock interviews

3 sample answers

Sample Answer 1:

In five years’ time, I see myself growing along with the team, developing and using new skills to the benefit of the organization. I find this position extremely motivating and exciting. I can imagine many challenges lying ahead of me, which I am excited to experience. And therefore, I am eager to invest my five years time learning all facets of the job towards professional advancement.

Sample Answer 2:

I am flexible with others and enjoy the roles that involves leadership. Although, my initial focus and priority would be to involve actively in the job I am applying for, I would very much keen to take management or supervisory role in 3-5 years…or less. I enjoy supporting my team members, and always try to set a good example for others.

Sample Answer 3:

I am obsessed to be the best at whatever I do. I would like to work in an organization where I’ll have the best chances to enhance my skills, doing interesting projects, and work along with team members that I can actually learn from. Some of the most innovative peers in the industry work here and that’s one of the reasons why I would love to built a career overhere.

Tips:

Analyze a reasonable career path which will flow from the position you are applying Try emphasize your interest and goal in your answer

Talk in terms of responsibilities and achievements

Try mentioning things that bring value to an organization

Fresher’s can put forward their plan for next one or two years instead of five or ten years

Show your long term interest in the position

What not to say

Don’t say this-

I am not sure, I am thinking about xyz…

Don’t portray yourself overly ambitious by saying something like……I want to be CEO in next five years

Don’t say that you wanted to be in the interviewer’s role or I want your job some-day Don’t put your personal plan like buying a new car or going for a long tour etc.

Why CDM?

All data should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification (GCP 2.10)

Data transformed during processing it should always be possible to compare the original data and observations with the processed data (ICH GCP 5.5.4).

India is poised to see tremendous growth in this field. The high availability of trainable talent is helping fuel this growth. Higher government and private investments in training students in the field of clinical research during the graduate and post-graduate curricula will help reduce the training costs that are borne by the industry today. With high growth expected, this would be a key area of focus for industry and academia alike.

Evolution?

CDM has evolved from a data entry process into a diverse process.
Provides clean data in a useable format in a timely manner and a database fit for use.
Ensures the data are clean & database is ready to lock.

CDM as a Science

Role of CDM in overall drug development organization is continuing to evolve.
Relationships with other organizations are continuing to be defined & developed.
CDM is a very visible & strong organization now.
Considered as an integral, respected, highly valued member of clinical development team.

OTHER PLAYERS ASSISTING CDMPERSONNEL IN CLINICAL RESEARCH

Core CDM Processes

DATA VALIDATION:

Design of Data Validation Strategy

Specification of Design

DATA ACQUISITION:

Data Collection Tool Design (paper)

Data Collection Tool Design (electronic)

DATA PROCESSING:

Forms Processing

Data Entry

Coding

Cleaning (manual clinical review & programmatic checks)

DATA STORAGE:

Database Structure Specification

Forms Management

Data Archival (paper & electronic)

LAB, SAFETY REPORTING & OTHER EXTERNAL DATA

Data Transfers & Loads

Database Reconciliation

DATA QUALITY:

Auditing

Quality Control Procedure

Statistical Sampling

Quantification of Database Quality

DATABASE CLOSURE:

Lock Criterion & Approval

Breaking the Blind

Handling of Post-lock Errata

Validation Checks

Range checks

To identify inaccurate or invalid data & statistical outliers

To ensure that data outside of permitted range are to be clarified & verified

Consistency checks

To highlight area where data in database are inconsistent

Presence checks

To ensure completeness of data

CRF Design

Design CRF along with protocol to assure collection of only data protocol specifies.

Guidelines to collect data through independent means Design CRF with primary safety & efficacy endpoints in mind as main goal of data collection.

Establish & maintain a library of standard forms CRF to be available for review at clinical site prior to approval.

The Data step creates an SAS dataset which carries the data along with a “data dictionary.” The data dictionary holds the information about the variables and their properties.

5) Explain what is PDV?

The logical area in the memory is represented by PDV or Program Data Vector. At the time, SAS creates a database of one observation at a time. An input buffer is created at the time of compilation which holds a record from an external file. The PDV is created following the input buffer creation.

6) Mention what are the data types does SAS contain?

The data types in SAS are Numeric and Character.

7) In SAS explain which statement does not perform automatic conversions in comparisons?

In SAS, the “where” statement does not perform automatic conversions in comparisons.

8) Explain how you can debug and test your SAS program?

You can debug and test your SAS program by using Obs=0 and systems options to trace the program execution in log

9) Mention what is the difference between nodupkey and nodup options?

The difference between the NODUP and NODUPKEY is that, NODUP compares all the variables in our dataset while NODUPKEY compares just the BY variables

10) Mention the validation tools used in SAS?

For DataSet: Data set name/ debug Data set: Name/stmtchk

For Macros: Options: mprint mlogic symbolgen

11) Explain what does PROC print, and PROC contents are used for?

To display the contents of the SAS dataset PROC print is used and also to assure that the data were read into SAS correctly. While, PROC CONTENTS display information about an SAS dataset.

12) Explain what is the use of function Proc summary?

The syntax of proc summary is same as that of proc means, it computes descriptive statistics on numeric variables in the SAS dataset.